Before recent trials were published, there was debate about the optimal secondary stroke prevention strategy for patients with a cryptogenic stroke or transient ischemic attack (TIA) who have a patent foramen ovale (PFO). Medical therapy and transcatheter device closure (TDC) have both been advocated as potential treatments. This article summarizes the evidence from trials comparing medical therapy to transcatheter device closure in patients with cryptogenic stroke and PFO. The following are six points to take away from this study:

The objective of this study was to compare the safety and efficacy of TDC to medical therapy (antiplatelet agent[s] and/or anticoagulation) in patients with PFO and cryptogenic stroke or TIA.

Using a Cochrane search as well as a review of article references and registries, the author found three randomized controlled trials involving 2,303 subjects that compared TDC to medical therapy. Baseline characteristics were similar across trials and the mean follow-up period was <5 years.

Intention-to-treat analyses showed no difference in recurrent stroke or TIA in the TDC group compared with the medical therapy group (risk ratio [RR], 0.73; 95% confidence interval [CI], 0.45-1.17).

When stroke alone (without TIA) was evaluated as an endpoint, there was still no difference between TDC and medical therapy (RR, 0.61; 95% CI, 0.29-1.27).

There was no difference in mortality between the two groups, but TDC increased the risk of developing atrial fibrillation (RR, 3.5; 95% CI, 1.47-8.35).

Ongoing trials and registries may help to establish if specific patient characteristics or transcatheter closure devices help clinicians identify patients who could benefit from PFO closure after cryptogenic stroke or TIA.